Centro Universitário FMABC, Santo André, SP, Brazil.
Sylvester Comprehensive Cancer Center, Miami, FL, United States.
Einstein (Sao Paulo). 2022 May 6;20:eGS6655. doi: 10.31744/einstein_journal/2022GS6655. eCollection 2022.
Human epidermal growth factor receptor 2 (HER2) overexpression occurs in up to 30% of breast cancer cases. Ado-trastuzumab emtansine (T-DM1) is approved to treat residual HER2-positive breast cancer after neoadjuvant therapy. The aim of this study was to determine the quality-adjusted time with symptoms or toxicity and without symptoms or toxicity (Q-TWiST) of T-DM1 compared to trastuzumab for residual invasive HER2-positive breast cancer.
The authors developed an analytical model extracting individual patient data and estimated invasive disease-free survival and overall survival over a 30-year time horizon. Only direct costs from adjuvant treatment were considered as well as relapse treatment from Brazilian and American payer perspectives. Heart events were considered for utility and cost analysis.
The 30-year projection utilizing the Weibull method estimated a mean invasive disease-free survival of 16.4 years for T-DM1 and 10.4 for Trastuzumab, in addition to a mean overall survival of 18.1 and 15.4 years, respectively. We determined a Q-TWiST gain of 3,812 years for the T-DM1 arm when compared to trastuzumab and an Incremental cost-effectiveness ratio per Q-TWiST of US$ 11,467.65 in the United States and US$ 3,332.73 in Brazil.
Ado-trastuzumab emtansine is cost-effective from both Brazilian and American perspectives.
人表皮生长因子受体 2（HER2）过表达发生在多达 30%的乳腺癌病例中。曲妥珠单抗-美坦新偶联物（T-DM1）被批准用于治疗新辅助治疗后残留的 HER2 阳性乳腺癌。本研究旨在确定 T-DM1 与曲妥珠单抗治疗残留浸润性 HER2 阳性乳腺癌的质量调整时间无病生存（Q-TWiST）和毒性无病生存（Q-TWiST）。
作者开发了一个分析模型，提取个体患者数据，并估计 30 年时间内的浸润性无病生存率和总生存率。仅考虑辅助治疗的直接成本，以及巴西和美国支付者角度的复发治疗。考虑了心脏事件对效用和成本分析的影响。
利用 Weibull 方法进行的 30 年预测估计 T-DM1 的平均浸润性无病生存率为 16.4 年，曲妥珠单抗为 10.4 年，此外，平均总生存率分别为 18.1 年和 15.4 年。与曲妥珠单抗相比，T-DM1 臂的 Q-TWiST 增益为 3812 年，在美国的增量成本效益比为每 Q-TWiST 11467.65 美元，在巴西为 3332.73 美元。
从巴西和美国的角度来看，曲妥珠单抗-美坦新偶联物是具有成本效益的。
